NCT02411513已完成1 期
Open-trial on the Acute Treatment of Migraine Using the CEFALY Device
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of pain intensity at 1 hour (VAS score)
研究概览
简要总结
The purpose of this study is to investigate the efficacy of e-TNS with the Cefaly® device as an acute treatment for a migraine attack. This open clinical trial will study the acute treatment of migraine using the Cefaly® device, prior to development of a sham-controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a history of episodic or chronic migraine with or without aura, meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine- recurrent painful ophthalmoplegic neuropathy, migrainous infarction)
- •The patient must be experiencing a migraine attack lasting for at least 3 hours, with pain intensity stabilized for at least 1 hour. The location of the headache should be frontal, retro- or peri- orbital, on one or either side.
排除标准
- •Pregnant women
- •Patients having received treatment with onabotulinum toxin (e.g., Botox, Dysport, Xeomin) to the head in the prior 4 months
- •Patients having received supraorbital nerve blocks in the prior 4 months
- •Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
- •Patients with only temporal or occipital headaches
- •Patients taking opioid medications
- •Patients having taken abortive migraine medication in the prior 3 hours
- •Allodynia: intolerance to supraorbital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded while the neurostimulation has already started).
- •Implanted metal or electrical devices in the head
- •Cardiac pacemaker or implanted or wearable defibrillator
结局指标
主要结局
Change of pain intensity at 1 hour (VAS score)
时间窗: 1 hour
Mean change in intensity of pain at 1 hour when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11
次要结局
- Change of pain intensity at 2 hours (VAS score)(2 hours)
- Patients with no need of medication at 2 hours(2 hours)
- Patients with no need of medication at 24 hours(24 hours)
研究者
研究点 (1)
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